Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- bladder function
研究概览
简要总结
The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.
详细描述
Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB (Overactive Bladder) in patients with SVMs after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- ••Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.
- •patient not received surgical or interventional treatment before
- •patient with normal cardiac, renal and hepatic function
- •patient capable of understanding the content of the patient information / Informed Consent Form
- •patient willing and able to participate in the registry
- •patients have consistent OAB after surgery
排除标准
- ••patient received surgical treatment or interventional treatment before
- •patient is pregnant
- •patient allergic to iodine
- •patient unable to complete follow-up
- •patient with cerebral lesions
- •patient with other spinal lesions
- •patient with cardiac, renal or hepatic dysfunction
研究组 & 干预措施
patients with SVMs receiving drug
patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist
干预措施: M receptor antagonist (Drug)
patients with SVMs undergoing SNM
patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
干预措施: surgery (Procedure)
patients with SVMs undergoing SNM
patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and undergo sacral neuromodulation (SNM)
干预措施: sacral neuromodulation (Procedure)
patients with SVMs receiving BTXA
patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
干预措施: surgery (Procedure)
patients with SVMs receiving BTXA
patients with SVMs are of consistent OAB after surgery and accept botulinum toxin A (BTXA) injection
干预措施: botulinum toxin A injection (Procedure)
patients with SVMs receiving drug
patients with SVMs are of consistent OAB (Overactive Bladder) after surgery and accept M receptor antagonist
干预措施: surgery (Procedure)
结局指标
主要结局
bladder function
时间窗: 3 months and 12 months
bladder function change in urodynamics
次要结局
未报告次要终点
研究者
ou tongwen
Director of Urology
Xuanwu Hospital, Beijing